Dataset Information

Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience.

ABSTRACT:

Background

Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Network piloted three novel mechanisms in the trial titled Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multi-site, randomized, double-blind, placebo-controlled trial in the pediatric intensive care setting.

Methods

The three novel start-up mechanisms included: 1) competitive activation; 2) use of trial start-up experts, called site navigators; and 3) supplemental funds earned for achieving pre-determined milestones. After sites were activated, they received a web-based survey to report perceptions of the DOSE start-up process. In addition to perceptions, metrics analyzed included milestones met, time to start-up, and subsequent enrollment of subjects.

Results

Twenty sites were selected for participation, with 19 sites being fully activated. Across activated sites, the median (quartile 1, quartile 3) time from receipt of regulatory documents to site activation was 82 days (68, 113). Sites reported that of the three novel mechanisms, the most motivating factor for expeditious activation was additional funding available for achieving start-up milestones, followed by site navigator assistance and then competitive site activation.

Conclusion

Study start-up is a critical time for the success of clinical trials, and innovative methods to minimize delays during start-up are needed. Milestone-based funds and site navigators were preferred mechanisms by sites participating in the DOSE study and may have contributed to the expeditious start-up timeline achieved.

Clinicaltrials

gov #: NCT03938857.

SUBMITTER: Boutzoukas AE

PROVIDER: S-EPMC9918704 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience.

Boutzoukas Angelique E AE Olson Rachel R Sellers Mary Ann MA Fischer Gwenyth G Hornik Chi D CD Alibrahim Omar O Iheagwara Kelechi K Abulebda Kamal K Bass Andora L AL Irby Katherine K Subbaswamy Anjali A Zivick Elizabeth E EE Sweney Jill J Stormorken Anne G AG Barker Erin E EE Lutfi Riad R McCrory Michael C MC Costello John M JM Ackerman Kate G KG Munoz Pareja Jennifer C JC Dean J Michael JM Abdelsamad Nael N Hanley Daniel F DF Mould W Andrew WA Lane Karen K Stroud Mary M Feger Bryan J BJ Greenberg Rachel G RG Smith P Brian PB Benjamin Daniel K DK Hornik Christoph P CP Zimmerman Kanecia O KO Becker Mara L ML

Contemporary clinical trials 20221225

<h4>Background</h4>Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Network piloted three novel mechanisms in the trial titled Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multi-site, randomized, double-blind, placebo-controlled trial in the pediatric intensive care se ...[more]

PMID: 36577492

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Dataset Information

Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience.

Background

Methods

Results

Conclusion

Clinicaltrials

Publications

Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience.

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